What is MoCRA?

Understanding the Modernization of Cosmetics Regulation Act of 2022

If you’re in the cosmetics industry—or even just a skincare enthusiast—you may have heard the acronym “MoCRA” floating around. But what exactly is MoCRA, and why does it matter?

A Major Shift in U.S. Cosmetics Law

MoCRA stands for the Modernization of Cosmetics Regulation Act, passed in 2022 as part of the U.S. Consolidated Appropriations Act. It’s the first major update to U.S. cosmetics law since 1938, bringing significant changes to how cosmetic products are regulated by the FDA.

Why Was MoCRA Needed?

For decades, the beauty and personal care industry operated under outdated laws that didn’t reflect modern science, global safety standards, or consumer expectations. With rising concerns about product safety, ingredient transparency, and brand accountability, MoCRA aims to close the gap—offering stronger protections for consumers and clearer guidelines for businesses.

What Does MoCRA Require?

Here are a few key changes under MoCRA:

• Facility Registration: Cosmetic manufacturers and processors must register their facilities with the FDA.

• Product Listings: Each marketed cosmetic product and its ingredients must be listed with the FDA.

• Adverse Event Reporting: Companies are required to report serious adverse events related to their products.

• Safety Substantiation: Brands must ensure and document that their products are safe for use.

• Labeling Requirements: Labels must now include contact information and disclose fragrance allergens.

• Mandatory Recall Authority: The FDA now has the power to recall cosmetic products deemed unsafe.

Who Does MoCRA Impact?

MoCRA affects all stakeholders in the cosmetics supply chain—from ingredient suppliers and manufacturers to brand owners and private labelers. Whether you’re a small indie brand or a global name, compliance is no longer optional.

When Does It Take Effect?

Most provisions began rolling out in late 2023 and early 2024, with further deadlines into 2025. The FDA has issued guidance documents to help businesses navigate this transition.

Why It Matters

MoCRA isn’t just a legal update—it’s a shift toward greater accountability, transparency, and consumer safety. For brands, it’s a wake-up call to tighten their quality systems and documentation. For consumers, it’s a sign that the industry is catching up to modern health and safety standards.

 

Need help navigating MoCRA? We’re here to support your compliance journey. Explore our COS-GMP documentation designed to align with MoCRA requirements.